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Bringing Health Home

NCT ID: NCT05160701

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-09

Study Completion Date

2026-09-30

Brief Summary

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Individuals suffering from Serious Mental Illnesses (SMI) are at risk for serious adverse health and social outcomes compared to the general population due to a high prevalence of chronic physical health disorders such as cardiovascular disease, hypertension, and Type II Diabetes, along with consequences of mental distress such as suicide, substance abuse, and acute stress.While pharmacological treatments exist for these conditions, they have limited effectiveness in SMI populations because: (1) up to 60% of individuals with SMI do not take their psychiatric or somatic medications as prescribed, (2) individuals with SMI have poorer clinical outcomes and experience high rates of hospitalizations, and (3) individuals with SMI experience worse care. Challenges in the management of these complex chronic health and mental health conditions have led to the development of intensive community-based service delivery programs. However, as currently structured these intensive in-person interventions have only had limited impact optimizing service delivery, and consequently on adherence to treatment and health outcomes. While in-person clinical contact in select situations is important, telehealth may serve as an effective and nimble intervention to help meet the high need for clinical intervention for SMI populations and particularly those with geographically limited-service access. Although research exists regarding the efficacy of telehealth with SMI populations, most of the existing interventions with this population have been designed for institutional settings, not community settings, because of barriers to adoption of telehealth such as limited access to digital technology, technical support difficulties and cost of necessary technology. The COVID-19 pandemic has underscored the need for developing effective telemedicine and telemonitoring technologies to serve the unique needs of this vulnerable population in community settings. This project builds on a successful Phase I SBIR project and ongoing Phase II clinical trial of the Medherent medication management platform. This study will test an expanded set of telehealth care-coordination services that can be used to address the broad health needs of individuals diagnosed with SMI living in community settings and supported by community mental health agencies. The study team will recruit 300 individuals, including 200 individuals currently using the device and 100 new users of the device. The study will test the existing Medherent platform and a set of extended services. Our key outcomes include acute service use, receipt of preventive and other health screenings, health outcomes and costs of services. The study will use a Stepped Wedge Design approach with a matched comparison group to identify potential benefits of the intervention.

Detailed Description

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Conditions

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Mental Disorders, Severe

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

To test our research aims we will use a stepped wedge cluster randomized design (SWD) and matched control group. All enrolled individuals will be grouped into a rollout unit. This unit could be comprised of individuals living in a group home or multiple group homes, a group of clients served by a case manager at an agency or a division of an agency. We anticipate that units will have approximately 10 - 15 clients and that we will have approximately 25 units across participating agencies. This design allows the study team to address problems with the rollout of the machines facilitating a good phase-in of the intervention for each unit. Third, this design addresses issues associated with the diffusion of the intervention within agencies that would occur with individual randomization while maintaining strong internal validity and assessment of the treatment effect.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Existing Medherent

Group using the Medherent Device with no added intervention components.

Group Type ACTIVE_COMPARATOR

Medherent

Intervention Type OTHER

Medherent is a telehealth adherence intervention platform designed for individuals with Serious Mental Illness living in the community. It is currently being used to dispense medication and monitor consumer adherence. It is a fully supported digital hub that is always on network connection and provides a cost- effective mechanism for increased care coordination through the Electronic Medication Record (EMR). The enhanced intervention will add collection of health data though Bluetooth connected devices, Telehealth medical visits and integrated algorithms that provide feed back to providers and consumers about health status.

New Medherent

Group using Medherent Device with added interventional components.

Group Type EXPERIMENTAL

Medherent

Intervention Type OTHER

Medherent is a telehealth adherence intervention platform designed for individuals with Serious Mental Illness living in the community. It is currently being used to dispense medication and monitor consumer adherence. It is a fully supported digital hub that is always on network connection and provides a cost- effective mechanism for increased care coordination through the Electronic Medication Record (EMR). The enhanced intervention will add collection of health data though Bluetooth connected devices, Telehealth medical visits and integrated algorithms that provide feed back to providers and consumers about health status.

Usual Care

Usual Care: no intervention elements.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Medherent

Medherent is a telehealth adherence intervention platform designed for individuals with Serious Mental Illness living in the community. It is currently being used to dispense medication and monitor consumer adherence. It is a fully supported digital hub that is always on network connection and provides a cost- effective mechanism for increased care coordination through the Electronic Medication Record (EMR). The enhanced intervention will add collection of health data though Bluetooth connected devices, Telehealth medical visits and integrated algorithms that provide feed back to providers and consumers about health status.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Serious Mental Illness Diagnosis
* Prescribed psychiatric medications
* 18 to 80 years old
* Receives services by a participating community mental health agency at time of enrollment
* Be unable to consent to the study as assessed by the consent questionnaire.
* Sample 1: Current Users of Medherent or
* Sample 2: Willing or able to authorize to have the Medherent device in your residence

Exclusion Criteria

• Unable to have the Medherent device in residence
Minimum Eligible Age

18 Years

Maximum Eligible Age

88 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Maryland, Baltimore

OTHER

Sponsor Role lead

Responsible Party

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George Unick

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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George Unick

Role: PRINCIPAL_INVESTIGATOR

University of Maryland

Locations

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University of Maryland

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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HP-00098021

Identifier Type: -

Identifier Source: org_study_id